FDA updates labels for three menopause hormone patches

The FDA approved updated prescribing information for three estradiol patches used for menopause hormone therapy, removing black-box warnings about breast cancer, cardiovascular disease and probable dementia, according to HHS and FDA reports. Healio reported that the products come from two applicants. The FDA Drugs page says prescribing information for the products has been updated.

The action follows label changes for six menopause hormone therapy products in February. The Guardian reported that FDA officials did not convene an advisory committee and gave few details about the scientific basis during a briefing. FDA officials said the agency is working with manufacturers to increase supply and update labels for remaining products. The Guardian reported that an expert criticized the lack of transparency and warned that removing warnings broadly could mislead patients.